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Clinical Research Associate Ii

2+ years
Not Disclosed
10 Dec. 14, 2024
Job Description
Job Type: Full Time Education: B.A./B.S Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here's a refined job description for the Clinical Research Associate 2 (CRA II) role at ICON Romania:


Position: Clinical Research Associate 2 (CRA II)

Location: Hybrid (Remote, with occasional office visits in Bucharest, Romania)
Company: ICON plc


About ICON

ICON is a world leader in the clinical research industry, offering comprehensive services powered by healthcare intelligence. As a part of our team, you’ll play a key role in advancing medical research to help patients and improve lives.


About the Role

As a Clinical Research Associate 2 (CRA II) at ICON, you will be responsible for monitoring and managing clinical trial sites, ensuring compliance with ICH-GCP, Sponsor SOPs, local laws, and regulations. You will play an integral role in site management throughout the lifecycle of clinical studies, including trial initiation, monitoring, and close-out visits. This is a sponsor-dedicated position within a hybrid work environment, with approximately one day per week spent at the sponsor’s office in Bucharest.


Key Responsibilities

  • Site Relationship Management: Build and maintain strong relationships with site staff to ensure smooth study execution.
  • Monitoring & Oversight: Conduct remote and on-site monitoring visits including initiation, validation, monitoring, and close-out visits.
  • Regulatory Documentation & Compliance: Ensure accurate and timely regulatory documentation is collected, reviewed, and maintained throughout the study phases.
  • Issue Resolution: Identify, assess, and resolve site performance, quality, or compliance issues, ensuring the study progresses according to protocol.
  • Collaboration & Coordination: Work closely with internal and external stakeholders, including country operations, finance, regulatory affairs, and vendors, to ensure study success.
  • Data Management & Documentation: Maintain accurate and up-to-date records in systems like CTMS, eTMF, and others as required.
  • Mentorship & Knowledge Sharing: Act as a Subject Matter Expert (SME), providing support, mentorship, and sharing best practices with other team members.
  • Audit Support: Assist in audit/inspection activities as needed, ensuring compliance at all stages of the trial.

Requirements

  • Education: B.A./B.S. in a science or biology-related field.
  • Experience: At least 2 years of direct site monitoring experience in bio/pharma/CRO, with proven expertise in site management and patient recruitment.
  • Skills:
    • Hands-on knowledge of Good Documentation Practices (GDP).
    • Strong IT skills and experience with clinical trial management systems.
    • Ability to analyze data and metrics to make informed decisions.
    • Strong problem-solving skills and the ability to perform root cause analysis.
  • Other: Strong communication skills and the ability to adapt to complex issues in a solution-oriented manner.

What ICON Offers

At ICON, we invest in our employees’ success and well-being. We offer competitive benefits to support a healthy work-life balance, including:

  • Various annual leave entitlements
  • Comprehensive health insurance for you and your family
  • Competitive retirement planning options
  • Life assurance
  • Global Employee Assistance Programme with access to 80,000+ specialists
  • Flexible benefits (e.g., childcare vouchers, gym memberships, subsidized travel passes)

For more information on the benefits ICON offers, visit our careers website.


Diversity & Inclusion at ICON

We are proud of our diverse workforce, which allows us to innovate and serve our global community better. ICON is committed to building an inclusive work environment and providing equal opportunities to all candidates, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you need reasonable accommodations due to a disability, please let us know through our reasonable accommodation form.


Interested?

If you’re passionate about clinical research and have the required experience, we encourage you to apply. If you are unsure whether you meet all the qualifications, don’t hesitate to apply—there’s a good chance you’re exactly what we’re looking for!


This job description highlights the key responsibilities and qualifications while also emphasizing ICON's commitment to diversity, employee well-being, and professional growth. Let me know if you need further adjustments!